Hepatera LLC and it`s development partner MYR GmbH today announced the initiation of MYR 203, a Phase 2b open label, randomized clinical trial to evaluate efficacy and safety of Myrcludex B in combination with pegylated interferon alpha versus pegylated interferon alpha in chronically HBV/HDV сo-infected patients. 60 subjects will be enrolled in 10 centers in Russia.
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"We plan to complete the recruitment by the end of 2016 and to have first results in Q3 2018," said Dr. Alexander Alexandrov, Medical Director MYR GmbH. "The primary objective of the study is improvement of the HDV RNA sustained virologic response rates, but we are certainly also looking if the combination of Myrcludex B with an immunomodulator can improve HBsAg loss rates and become a milestone on the way to the HBV cure. The results of this trial will be complementary to the ongoing Phase 2b trial of Myrcludex on top of tenofovir in chronic HBV/HDV infection."
"Whereas pegylated interferon alpha is a de-facto treatment standard for hepatitis delta, the unmet need remains huge," said Pietro Lampertico, MD, Professor at University of Milan and member of MYR`s Clinical Advisory Board. "Myrcludex B has shown synergistic effects in combination with interferon in the previous trial, so we look forward to see if this novel drug can improve treatment outcomes in this devastating disease."
About Myrcludex B
Myrcludex B is a first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections. The drug inhibits the recently identified HBV receptor on the hepatocyte surface and prevents the infection of healthy cells and viral spreading within the liver.
Hepatera is a biotechnology company. The main activity of the company is development of safe and effective drugs for the treatment of liver diseases for the Russian market.
About MYR GmbH
MYR GmbH is a biotechnology company focused on drugs for the treatment of chronic hepatitis B and D virus infections. The company is supported by investors Maxwell Biotech and High-Tech Gründerfonds.
About Maxwell Biotech Venture Fund
MBVF is the first Russian venture fund fully dedicated to investments in the life sciences sector. The fund has been created with participation of the Russian Venture Company. MBVF portfolio companies have nine innovative clinical drug candidates in development.